Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate

Job Summary:

The Senior Associate of Regulatory Affairs will be responsible for supporting day-to-day regulatory activities, with a focus on the review, compilation, and submission of regulatory dossiers for new product submissions and post-approval applications. This role will primarily focus on complex injectable and sterile dosage forms and will involve close collaboration with cross-functional teams (R&D, QA, Project Management) and external partners (CMOs, CROs, and contract labs). The Senior Associate will play a key role in ensuring compliance with global regulatory requirements and timelines, reporting directly to the Regulatory Affairs Team Lead.

Key Responsibilities:

1. Regulatory Submission Management:

• Review, compile, and submit regulatory dossiers for new product submissions (ANDAs, NDAs) and post-approval submissions (supplements, amendments) for global markets.
• Ensure all submissions meet regulatory requirements, with a focus on complex injectable and sterile dosage forms.
• Maintain submission timelines and coordinate with internal teams and external partners to gather necessary documentation for filings.

2. Regulatory Operations Support:

• Assist in the day-to-day operations of the Regulatory Affairs (RA) team, ensuring efficient workflow and timely submissions.
• Monitor and track regulatory submission activities, ensuring that all tasks are completed according to regulatory timelines and business priorities.
• Maintain regulatory databases and submission logs, ensuring accurate record-keeping and tracking.

3. Cross-Functional Collaboration:

• Collaborate with cross-functional teams, including R&D, Quality Assurance (QA), and Project Management (PM), to obtain necessary documentation and data for regulatory filings.
• Work closely with external partners, including Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), and contract laboratories to coordinate regulatory submissions and ensure compliance with required guidelines.

4. Documentation and Regulatory Compliance:

• Review and ensure the accuracy and completeness of regulatory documents, including Module 1, 2, 3, and other relevant sections of the submission dossier.
• Ensure all submissions comply with FDA and global regulatory requirements, including ICH, EU, and other regional guidelines.
• Stay current with changes in regulatory requirements and proactively implement necessary updates to submission processes.

5. Post-Approval Submission Activities:

• Assist in the preparation and submission of post-approval supplements, labeling updates, and CMC (Chemistry, Manufacturing, and Controls) amendments.
• Monitor ongoing regulatory requirements for approved products, ensuring continuous compliance with global regulations.

6. Communication and Reporting:

• Provide regular updates to the Regulatory Affairs Team Lead on submission status, regulatory developments, and project progress.
• Coordinate with internal stakeholders to ensure alignment on regulatory strategies and timelines.

7. Process Improvement:

• Support the development and implementation of standardized processes and templates for regulatory submissions.
• Proactively identify opportunities to improve regulatory workflows and optimize submission timelines.

Qualifications

• Education: Bachelor’s or Master’s degree in life sciences, pharmacy, or related field.
• Experience:
  • Minimum 6 years of experience in Regulatory Affairs, with a focus on complex injectable and sterile dosage forms.
  • Experience in the review, compilation, and submission of regulatory dossiers for ANDAs or NDAs.
  • Experience working with global regulatory agencies (e.g., FDA, EMA).
• Skills:
  • Strong understanding of regulatory requirements for injectable and sterile dosage forms.
  • Experience working with cross-functional teams and external partners (CMOs, CROs).
  • Excellent organizational, communication, and time management skills.
  • Familiarity with eCTD submission formats and regulatory submission software.

Preferred Qualifications:

• Experience in post-approval submissions and lifecycle management for generic products.
• Familiarity with regulatory requirements for global markets (e.g., US, EU, Canada, ROW).
• Proficiency in using Regulatory Information Management Systems (RIMS).

Salary : $10 - $13